FDA Moves 12 Peptides Out of Category 2: What Secretary Kennedy's Announcement Means
HHS Secretary Kennedy announced April 15, 2026 that the FDA will begin removing 12 peptides from Category 2. Here is what happened, which compounds are affected, and what comes next.
Today, HHS Secretary Robert F. Kennedy Jr. announced that the FDA will begin removing 12 peptides from Category 2 of the Section 503A Bulk Drug Substances list.
The peptides moving forward for re-evaluation include BPC-157, Thymosin beta-4 fragment (TB-500), Epitalon, GHK-Cu (injectable), MOTS-c, DSIP (Emideltide), Dihexa Acetate, Ibutamoren Mesylate (MK-677), Melanotan II, KPV, Semax, and Cathelicidin LL-37.
These compounds were placed in Category 2 back in September 2023. According to the announcement, the goal is to restore regulated access and reduce reliance on the unregulated black market.
Next steps are clear. The FDA will bring these substances before the Pharmacy Compounding Advisory Committee at its next two meetings, starting in July 2026. Independent experts will review clinical, pharmacological, and safety data before any final decision is made.
Nine of these 12 peptides are already documented in our database. We will update their individual pages as soon as the FDA releases the formal list and meeting agenda.
This development could mark an important shift for researchers, compounding pharmacies, and others interested in peptide science. It may open the door to more regulated access, but only after the full review process is complete.
Peply remains a neutral reference tool. This post simply summarizes publicly available information. We do not offer medical advice, endorsements, or predictions about final regulatory outcomes. All compounds listed continue to be for research use only until the FDA completes its process.
For the full compound-by-compound status, see the Regulatory Tracker.
Source: Secretary Kennedy's public statement, April 15, 2026.
Related compounds
BPC-157
Gastric pentadecapeptide researched for tissue repair, angiogenesis, and anti-inflammatory effects. Not FDA-approved for any indication.
TB-500
Synthetic fragment of Thymosin Beta-4 researched for tissue repair, cell migration, and anti-inflammatory effects. Not FDA-approved for any indication.
Epitalon (Epithalon)
Synthetic tetrapeptide researched for telomerase activation and pineal gland function. Not FDA-approved for any indication.
GHK-Cu
Naturally occurring copper-binding tripeptide researched for wound healing, collagen synthesis, and tissue remodeling. Not FDA-approved for any indication.
MOTS-C (Mitochondrial ORF of the 12S rRNA Type-C)
Mitochondrial-derived peptide researched for metabolic regulation and insulin sensitivity. Not FDA-approved for any indication.
DSIP (Delta Sleep-Inducing Peptide / Emideltide)
Nonapeptide researched for sleep architecture modulation and stress-related cortisol regulation. Not FDA-approved for any indication.
KPV (Lys-Pro-Val)
Anti-inflammatory tripeptide fragment of alpha-MSH researched for gut and mucosal immune modulation. Not FDA-approved for any indication.
Semax
Synthetic analog of ACTH (4-10) fragment researched for neuroprotective and cognitive-enhancing effects. Approved in Russia; not FDA-approved in the US.
MK-677
Non-peptide, orally active growth hormone secretagogue. Mimics ghrelin at the GHS-R1a receptor to stimulate endogenous GH release. Investigational — not FDA-approved for any indication. Administered orally, so reconstitution calculations do not apply.